title: Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy.
abstract: BACKGROUND
  Patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) often continue to experience symptoms despite receiving standard-of-care therapy with H1-antihistamines along with 1 or more add-on therapies.
  
  
  OBJECTIVE
  We sought to evaluate the safety and efficacy of 24 weeks of treatment with omalizumab in patients with persistent CIU/CSU despite treatment with H₁-antihistamines at up to 4 times the approved dose plus H₂-antihistamines, leukotriene receptor antagonists, or both.
  
  
  METHODS
  In this phase III study patients were randomized to receive 6 subcutaneous injections at 4-week intervals of either 300 mg of omalizumab or placebo, followed by a 16-week observation period. The primary objective of the study was to evaluate the overall safety of omalizumab compared with placebo. Efficacy (itch severity, hive, and urticaria activity scores) was evaluated at weeks 12 and 24.
  
  
  RESULTS
  The overall incidence and severity of adverse events and serious adverse events were similar between omalizumab and placebo recipients; the safety profile was consistent with omalizumab in patients with allergic asthma. At week 12, the mean change from baseline in weekly itch severity score was -8.6 (95% CI, -9.3 to -7.8) in the omalizumab group compared with -4.0 (95% CI, -5.3 to -2.7) in the placebo group (P < .001). Significant improvements were seen for additional efficacy end points at week 12; these benefits were sustained to week 24.
  
  
  CONCLUSIONS
  Omalizumab was well tolerated and reduced the signs and symptoms of CIU/CSU in patients who remained symptomatic despite the use of H₁-antihistamines (up to 4 times the approved dose) plus H₂-antihistamines, leukotriene receptor antagonists, or both.
authors.affiliation: Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Allen
authors.initials: A
authors.lastname: Kaplan
authors.forename: Dennis
authors.initials: D
authors.lastname: Ledford
authors.forename: Mark
authors.initials: M
authors.lastname: Ashby
authors.forename: Janice
authors.initials: J
authors.lastname: Canvin
authors.forename: James L
authors.initials: JL
authors.lastname: Zazzali
authors.forename: Edward
authors.initials: E
authors.lastname: Conner
authors.forename: Joachim
authors.initials: J
authors.lastname: Veith
authors.forename: Nikhil
authors.initials: N
authors.lastname: Kamath
authors.forename: Petra
authors.initials: P
authors.lastname: Staubach
authors.forename: Thilo
authors.initials: T
authors.lastname: Jakob
authors.forename: Robert G
authors.initials: RG
authors.lastname: Stirling
authors.forename: Piotr
authors.initials: P
authors.lastname: Kuna
authors.forename: William
authors.initials: W
authors.lastname: Berger
authors.forename: Marcus
authors.initials: M
authors.lastname: Maurer
authors.forename: Karin
authors.initials: K
authors.lastname: Rosén
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002908:Chronic Disease; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D014581:Urticaria / Q000188:drug therapy*
chemical_list: D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab